The once-daily eyedrop is a fixed-dose combination of latanoprost, the most widely prescribed prostaglandin analog (PGA), and netarsudil, the active ingredient in netarsudil ophthalmic solution 0.02% (Rhopressa), a first-in-class Rho kinase (ROCK) inhibitor specifically designed to target the trabecular meshwork (the eye’s principal drainage pathway). The diseased trabecular meshwork is considered to be the main cause of elevated IOP in open-angle glaucoma and ocular hypertension.

Netarsudil works by restoring outflow through the trabecular meshwork, while latanoprost increases fluid outflow through a secondary mechanism known as the uveoscleral pathway.

Approval was based on data from two Phase III registration trials, in which the agent achieved its primary 90-day efficacy endpoint as well as positive 12-month safety and efficacy results, demonstrating statistically superior IOP reduction over latanoprost and netarsudil at every measured timepoint.

Treatment was associated with generally mild and tolerable ocular adverse events, with minimal systemic side effects. The most common ocular adverse event in controlled clinical studies was conjunctival hyperemia. Ninety percent of patients who experienced hyperemia reported it as mild, and 5% discontinued because of it.

Other common ocular adverse effects were instillation-site pain, corneal verticillata, and conjunctival hemorrhage.

Aerie plans to launch the new product in the United States in the second quarter of 2019.

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